(252 days)
The InfraReDx NIR System is intended for the near infrared imaging of the coronary arteries.
The InfraReDx Near Infrared (NIR) Imaging system is comprised of the catheter, catheter accessories, pull-back and rotation device and laser console with accessories.
Here's a breakdown of the acceptance criteria and study information for the InfraReDx Near Infrared (NIR) Imaging System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standards Compliance: | Complies with ISO 60601-1, ISO 60601-2-22, CSA22.2 No.601.1, CSA Z386-01, IEC 60825-1, ANSI Z136.1-2000, and ISO 10993 (for transient blood contacting devices). |
| Intended Functionality: | Preclinical testing has shown that the product can function as intended. |
| Internal Design Specifications: | Preclinical testing has shown that the product meets all internal design specifications. |
| Substantial Equivalence to Predicate Devices: | The device has similar indications statements and identical functionality to predicate devices for imaging coronary vasculature. Its output (image of the artery) as an adjunct to coronary angiography is similar to predicate devices. |
Study Details:
Based on the provided 510(k) summary, the device's acceptance was primarily based on adherence to established safety and performance standards for medical devices and a demonstration of substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic accuracy against a specific ground truth.
Here's an analysis of the requested information:
2. Sample Size Used for the Test Set and Data Provenance:
The document describes preclinical testing to demonstrate compliance with standards and internal design specifications. It does not mention a "test set" in the context of clinical data for diagnostic performance. Therefore, there is no sample size or data provenance (country of origin, retrospective/prospective) for a diagnostic test set in the provided summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The submission focuses on device safety and functional conformity through preclinical testing and comparison to predicate devices, not on a study requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set:
Not applicable. There is no diagnostic test set described in the provided information that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No. The document does not mention an MRMC comparative effectiveness study or any data on how human readers improve with or without AI assistance. The device is for NIR imaging, not an AI-assisted diagnostic tool in the sense of interpreting images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The device is an imaging system, not an algorithm, and its performance is evaluated in terms of its ability to produce images and meet safety standards.
7. The Type of Ground Truth Used:
The "ground truth" implicitly used for this submission is related to:
- Compliance with recognized electrical, mechanical, and biological safety standards (e.g., ISO, CSA, IEC, ANSI).
- Adherence to the manufacturer's own internal design specifications.
- Functional similarity to already legally marketed predicate devices.
There is no mention of a ground truth for diagnostic accuracy (e.g., pathology, outcomes data, or expert consensus on image interpretation) in the context of a clinical study.
8. The Sample Size for the Training Set:
Not applicable. This device is an imaging system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/ML algorithm mentioned.
Summary of the Study's Nature:
The 510(k) submission for the InfraReDx Near Infrared (NIR) Imaging System, Model MC-5, primarily relies on demonstrating substantial equivalence to legally marketed predicate devices. This is a common pathway for medical devices that are similar in technology, intended use, and performance characteristics to devices already on the market.
The "performance data" cited in the summary revolves around:
- Compliance with a comprehensive list of international and national safety and performance standards for medical electrical equipment, laser safety, and biocompatibility.
- Preclinical testing to confirm that the device functions as intended and meets its internal design specifications.
The submission does not involve a clinical efficacy study, a multi-reader study, or the use of AI/ML algorithms requiring training and test sets with expert-adjudicated ground truth. Its acceptance criteria are based on fundamental safety, performance, and equivalence to existing technologies.
{0}------------------------------------------------
510(K) SUMMARY K052908 InfraReDx Near Infrared (NIR) Imaging System
| Submitter Name: | InfraReDx JUN 2 3 2006 |
|---|---|
| Submitter Address: | 34 Third AvenueBurlington, MA 01803 |
| Contact Person: | Nandini Murthy, V.P. Clinical and Regulatory Affairs |
| Phone Number: | (781) 221-0053, Extn 221 |
| Fax Number: | (781) 272-5290 |
| Date Prepared: | October 13, 2005 (Amended: June 8, 2006) |
| Device Trade Name: | InfraReDx Near Infrared (NIR) Imaging System, Model MC-5 |
| Device Common Name: | Near Infrared (NIR) Imaging System |
| Predicate Devices: | Boston Scientific Galaxy IVUS System, Boston ScientificAtlantis SR, SR Pro and SR Plus IVUS catheterVolcano Revolution and Eagle Eye Gold IVUS catheter, IVUSsystemBaxter Imagecath Coronary AngioscopeAmerican Edwards Angioscopy catheter/systemCardio-Optics CSA System |
| Device Description: | The InfraReDx Near Infrared (NIR) Imaging system iscomprised of the catheter, catheter accessories, pull-back androtation device and laser console with accessories. |
| Intended Use: | The InfraReDx Near Infrared (NIR) Imaging System is intendedfor the near infrared imaging of the coronary arteries. |
| Performance Data: | The InfraReDx Near Infrared (NIR) Imaging System complieswith applicable safety and performance standards, ISO 60601-1,ISO 60601-2-22, CSA22.2 No.601.1, CSA Z386-01, IEC 60825-1, ANSI Z136.1-2000 and ISO 10993 (for transient bloodcontacting devices). Further preclinical testing has shown thatthe product can function as intended and meets all internaldesign specifications. |
| Conclusion: | The InfraReDx Near Infrared (NIR) Imaging System has similarindications statements as the predicate devices. All are used forimaging of the coronary vasculature. The functionality of theInfraReDx System and predicate devices is identical. Thecatheter accesses the coronary vasculature via the femoral orradial access site and tracks on the existing guidewire as usedduring routine PCI. The device output is an image of the artery,as an adjunct to coronary angiography, and is similar to thepredicate devices. Therefore the InfraReDx NIR Imaging Systemis substantially equivalent to the predicate devices. |
の - 100 - 1000 - 1000 - 1000 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100
6/8/2006
Page 1 of l
1999 - 1999 - 1998
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with a staff entwined by two snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2006
InfraReDx, Inc. Ms. Nandini Murthy Vice President, Clinical and Regulatory Affairs 34 Third Avenue Burlington MA 01803
Re: K052908
Trade/Device Name: InfraReDx NIR Imaging System, Model MC-5 Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II (performance standards) Product Code: DOO Dated: April 24, 2006 Received: April 25, 2006
Dear Ms. Murthy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition. HDA way publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements aft the Act or any Federal statutes and regulations administered by other Federal agencies. Your must comply with all the Act s requirements, including, but not limited to: registration and listing (21
{2}------------------------------------------------
Page 2 - Ms. Nandini Murthy
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permitte vor device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bymmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): K052908
Device Name: InfraReDx Near Infrared (NIR) Imaging System
Indications For Use:
The InfraReDx NIR System is intended for the near infrared imaging of the coronary arteries.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Concurrence of CDRH, Office of Device Evaluation (ODE) /
B. Bannister.
(División Sign-Off) Division of Cardiovascular Devices 510(k) Number_ KOS 290X
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).